4.1.7 Drug regulation

Drug Regulation

The regulation of drugs in the United Kingdom is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA), which is an executive agency of the Department of Health and Social Care. The agency’s main aim is to ensure that medicines and medical devices available in the UK are safe, effective, and of appropriate quality (MHRA, 2023).

The MHRA is responsible for a number of key functions related to drug regulation in the UK, including:

MHRA function:	Description:
Approving new medicines	The MHRA is responsible for assessing the safety, efficacy, and quality of new drugs before they can be made available for use in the UK. This process involves reviewing clinical trial data and other scientific evidence to determine whether a drug is safe and effective for its intended use.
Monitoring drug safety	Once a drug has been approved for use in the UK, the MHRA continues to monitor its safety and effectiveness, and take action to address any issues that arise. This can include updating guidance on the use of a drug, withdrawing a drug from the market, or requiring additional warnings to be added to the product information.
Regulating medical devices	The MHRA is also responsible for regulating medical devices in the UK, including everything from simple bandages and surgical instruments to complex medical devices such as pacemakers and artificial joints.
Providing information and advice	The MHRA provides information and advice to healthcare professionals, patients, and the public on a wide range of drug and medical device-related issues.

The UK drug regulation system is designed to ensure that drugs and medical devices available in the country are safe and effective for their intended use. This helps to protect public health and ensure that patients receive the best possible care. However, the system is also flexible enough to respond to new information and developments and to take action to address any concerns that arise.

The purposes and processes of licensing:

The purpose of licensing is to ensure that drugs and medical devices are safe, effective, and of an appropriate quality for use in the UK. The licensing process is a way of regulating the availability and use of these products and is intended to protect public health and ensure that patients receive the best possible care.

The licensing process typically involves the following steps:

1. Pre-clinical testing: Before a new drug or medical device can be considered for approval, it must undergo pre-clinical testing to determine its safety and efficacy. This typically involves laboratory and animal studies to assess the product’s safety profile and determine its potential for use in humans.
2. Clinical trials: If pre-clinical testing indicates that a product is safe and has the potential for use in humans, the next step is to conduct clinical trials. These trials are designed to assess the safety and efficacy of the product in humans and to determine the best way to use the product to achieve the desired therapeutic effect.
3. Application for marketing authorization: If the results of the clinical trials are positive, the manufacturer of the product can submit an application for marketing authorization to the relevant regulatory authority, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
4. Review and assessment: The regulatory authority will review the application and assess the evidence submitted, including the results of the pre-clinical and clinical trials. This will involve a detailed assessment of the product’s safety, efficacy, and quality, and a consideration of any potential risks and benefits.
5. Decision on marketing authorization: If the regulatory authority is satisfied that the product is safe, effective, and of appropriate quality, it will grant marketing authorization, allowing the product to be made available for use in the UK.

The licensing process is designed to ensure that drugs and medical devices are safe, effective, and of an appropriate quality for use in the UK. This helps to protect public health and ensure that patients receive the best possible care, and provides confidence in the products available for use. The licensing process is ongoing, and the regulatory authority will continue to monitor the safety and effectiveness of licensed products to ensure that they remain safe and effective over time.

‘Approved’ versus ‘off-label’:

“Approved” refers to a drug or medical device that has been granted marketing authorization by a regulatory authority, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This means that the product has been deemed safe, effective, and of an appropriate quality for its intended use, based on the results of pre-clinical and clinical trials.

“Off-label” refers to the use of a drug or medical device for a purpose that is different from its approved indication. For example, a drug may be approved for the treatment of one condition, but a doctor may choose to prescribe it for another condition, not officially approved by the regulatory authority.

Off-label use of drugs and medical devices is common in some medical specialities, including psychiatry, where there may be limited options for the treatment of certain conditions. In some cases, off-label use may be based on anecdotal evidence or limited clinical trials, rather than on robust scientific data.

It is important to note that off-label use of drugs and medical devices is not necessarily unsafe or ineffective, but it may not have been fully evaluated by the regulatory authority, and there may be limited data available on its safety and efficacy. As a result, the decision to use a product off-label should be based on careful consideration of the risks and benefits and should be made in consultation with a qualified healthcare professional (NICE, 2017).

Branded versus generic drugs:

Branded drugs and generic drugs are two different types of medications that are available for use in the UK.

A branded drug, also known as an originator drug, is a medication that has been developed and marketed by a pharmaceutical company under a specific brand name. Branded drugs are usually the first medications to be approved for the treatment of a particular condition, and they are typically more expensive than generic drugs.

A generic drug, on the other hand, is a medication that is identical to a branded drug in terms of safety, efficacy, and quality but is sold under a different name and at a lower price. Generic drugs are made available after the patent on the original branded drug has expired, allowing other pharmaceutical companies to produce and sell the medication at a lower cost.

Both branded drugs and generic drugs must undergo rigorous testing and assessment by regulatory authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, to ensure their safety, efficacy, and quality. Once a drug has been approved, whether it is a branded drug or a generic drug, it must continue to meet the same standards for quality and safety, and must be subject to ongoing monitoring by the regulatory authority.

In summary, both branded drugs and generic drugs are safe, effective, and of an appropriate quality for their intended use. The main difference between the two is the name and cost of the medication, with branded drugs being more expensive than generic drugs (EMA, 2023).

References:

(1) European Medicines Agency (EMA). 2023. (n.d.). What is a generic medicine? Retrieved from https://www.ema.europa.eu/en/human-regulatory/post-authorisation/generic-medicines

National Institute for Health and Care Excellence (NICE). (2017). Off-label and unlicensed medicines. Retrieved from https://www.nice.org.uk/guidance/ph56/resources/off-label-and-unlicensed-medicines-pdf-351097755

UK Medicines and Healthcare products Regulatory Agency (MHRA). 2023. (n.d.). About us. Retrieved from https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency